Surgical device for retracting and/or sealing an incision

ABSTRACT

A wound protector and retractor device comprising a longitudinal axis, a distal ring, a proximal ring, and a sleeve extending between the distal ring and the proximal ring. The sleeve is fixed to the proximal ring at a first end portion and axially slidable over the proximal ring at a second end portion.

This application is a continuation of U.S. application Ser. No.09/801,826, filed Mar. 9, 2001, now abandoned, which is a continuationof PCT International Application No. PCT/IE99/00122, filed Dec. 1, 1999,both of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates to a surgical device. More specifically,the invention relates to devices for retraction of an incision ornatural bodily opening during surgery and for protecting the edges orincisions from infection or tumour seeding during surgery.

Wound Retraction

Adequate anatomical exposure is required in modem surgical procedures toallow procedures to be safely and effectively performed. Anatomicalexposure is achieved by separating the walls of a natural orifice orspreading apart the margins of a surgical incision. A difficult surgicalprocedure can be simplified by adequate retraction whereas a relativelysimple procedure can be made more difficult or even dangerous by thelack of adequate retraction. Exposure is maximised with correct incisionplacement and well directed retraction.

Retraction can be achieved in several different ways. The most commonmethod of surgical wound retraction is by the use of hand heldretractors. These may be made of metal or thermoplastics and allow anoperator to apply a retraction force to the wound edges. They aredisposable or reusable and come in a variety of shapes and sizes tosatisfy the requirements of different surgical procedures.

Another type of retractor are Frame mounted retractor devices are alsoknown. Such devices consist of a rigid circular or horseshoe-shapedframe on which multiple, detachable and movable paddle retractors areattached. The device may be mounted to an operating table to providesecure anchorage. Retraction may be applied in required directions.Typically such retractors are made of stainless steel to facilitatecleaning and sterilisation for reuse. Some of the more complex retactorsneed to be taken apart before sterilisation and reassembled before use.These devices always apply retraction at a fewspecific locations on thewound. This is a disadvantage of such devices as it can lead to regionalischaemia on parts the wound edge.

A wound retractor, and protector is disclosed in U.S. Pat. No. 5,524,644(Crook). This device consists of an open-ended sleeve of polymericmaterial with a flexible ring at each end. One ring is inserted into theincision and the sleeve is manually rolled up around the other ring toapply tension to the polymeric material to achieve retraction. Thedevice is often difficult to use because of the manual dexterityrequired, especially when the surgeons hands are wet. In addition, thedevice is incrementally adjustable. This restricts the efficiency of thedevice across all abdominal wall thicknesses.

U.S. Pat. No. 5,545,179 (Williamson IV) describes a device having anelastomeric sealing element and a tubing conduit. The device protectsthe edges of the wound from contamination. However, the device isspecifically for laparoscopic instruments and is not suitable for handassisted surgery because the wound opening is not sufficientlyretracted.

WO-A-96/36283 (Mollenauer) describes a trocar device for retracting andsealing an incision and providing a sealed access port for surgicalinstruments. Whilst this incision and providing a sealed access port forsurgical instruments. Whilst this device provides both retraction andprotection to the wound edge is not suitable for use in hand assistedsurgery due to size limitations. The device retarcts and protects due tothe inflation of one or one or more balloons and because these close thelumen when inflated it is not possible to visulaise the contents of theabdomen through the device.

WO-A-98/48724 discloses a device for use in hand assisted laparoscopicsurgery. The device has a wound retractor/protector component and acomponent for sealing around the wrist of the surgeon. The woundprotector component consists of an inner ring and two outer inflatabledoughnut-shaped rings mounted vertically on top of another. The innerand outer rings are linked by an elastomeric sleeve. Inflation of thetwo outer rings causes retraction of the elastomeric sleeve. This deviceprovides wound retraction and protection but it is not suitable fordevice has a large vertical profile due to the outer rings. Thisrestructs reach into the incision and extends the fulcrum of anyinstruments used in such a way that their effective reach and breath oflateral movement would be severely restricted.

Wound Protection

The sides of an open wound are susceptible to infection and crosscontamination if they are touched by contaminated material such as bodyparts or fluids as they pass through the opening of a wound. Seriousproblems can also result from cancerous material coming into contactwith the wound edge. It is well known that cancerous cells may becomeseeded in wound areas, especially at trocar sites.

To avoid such problems great care is taken to protect the edges of anincision using drapes that are impervious to liquids. An incision lineris disclosed in U.S. Pat. No. 3,397,692 (Creager). This linear comprisesa sheet of polymeric material. The sheet has a hole cut out in thecentre and the edges of the hole are reinforced using a semi-rigid ring.This ring can be inserted into the incision allowing a surgicalprocedure to proceed through the ring while the material attached to thering protects the edges of the incision from contaminants in the woundsite. These device marketed as “Steridrape” by 3M Corporation and comesin a variety of sizes for different wound sizes. However such devices donot adequately retract an incision.

In general known devices are of either complex construction, do noteffectively seal a wound and/or are difficult to operate.

There is therefore a need for an improved surgical device that willovercome at least some of these problems.

Statements of Invention

According to the invention there is provided a surgical devicecomprising:

-   -   an inner mounting means for insertion through a wound opening;    -   a first outer mounting means for mounting external of a wound        opening; and    -   connecting means extending between the inner and outer mounting        means;    -   the connecting means being movable to shorten the axial extent        of the connecting means.

In a particularly preferred embodiment of the invention the outermounting means is movable relative to the inner mounting means to twistthe connecting means to form a lumen of reduced cross section and toshorten the axial extent of the connecting means.

Most preferably the outer mounting means is rotatable relative to theinner mounting means to twist the connecting means.

In a particularly preferred embodiment of the invention the connectingmeans is a sleeve of pliable material extending between the inner andouter mounting means.

In one aspect the device includes a second outer mounting means, theconnecting means extending between the first outer mounting means, theinner mounting means, and the second outer mounting means.

In this case preferably the first and second outer mounting means arerotatable relative to one another to twist the connecting means and todraw the inner mounting means towards the outer mounting means. Theouter rings also rotate relative to the inner mounting means.

In a particularly preferred embodiment the inner mounting means is anO-ring. Preferably the connecting means is a sleeve which is led fromthe first outer mounting means to the O-ring and from the O-ring to thesecond outer mounting means.

In a preferred embodiment of the invention the device includes lockingmeans for locking the first outer mounting means relative to the secondouter mounting means.

In one arrangement one of the outer mounting means is located orlocatable within the other outer mounting means.

Preferably the inner diameter of the sleeve is greater than or equal tothe axial length of the sleeve.

In a preferred arrangement the inner diameter of the sleeve is greaterthan the axial length of the sleeve by an amount less than the thicknessof an average abdominal wall, which is typically 2 to 6 cm. This assistsin achieving a retraction force.

Preferably a substantially gas tight seal is formed between the outermounting means on shortening of the length of the sleeve. Ideally, thesleeve extending between the first and second outer mounting meansdefines an inflatable space.

In one embodiment of the invention the device includes a port forconnection to an inflation means.

The invention also provides a surgical device comprising:

-   -   an inner mounting means for insertion through a wound opening;    -   a first outer mounting means;    -   a second outer mounting means; and    -   a sleeve of pliable material extending from the second outer        mounting means to the inner mounting means and from the inner        mounting means to the first outer mounting means.

Preferably one or both of the first and second outer mounting means aremovable relative to one another to adjust the diameter of the lumendefined by a twist in the sleeve extending therebetween.

Ideally, the first and second outer mounting means are rotatablerelative to one another.

In one embodiment of the invention the sleeve is releasably mounted tothe second outer mounting means for adjustment of the length of thesleeve.

Preferably the second mounting means comprises a receiver and the sleeveis mounted or mountable to a ring which is releasably mounted to thereceiver.

In another embodiment of the invention the inner mounting means isconfigured to reduce the size thereof for ease of insertion into a woundopening.

Typically in this case the inner mounting means comprises a ring whichincludes a hinge means for reducing the size of the ring.

A device as claimed in claim 1 wherein the connecting means istranslated to shorten the axial extent of the connecting means.

A device as claimed in claim 23 wherein the connecting means comprises asleeve which is translated by a drawstring mechanism.

A device as claimed in claim 24 wherein the connecting means comprises aplurality of straps attached to the inner mounting means, the strapsbeing pulled upwardly to shorten the axial extend of the connectingmeans.

Typically the outer mounting means includes a holder for holding asurgical instrument.

The surgical device may form a wound retractor, a wound protector or awound protector retractor.

BRIEF DESCRIPTION OF DRAWINGS

The invention will be more clearly understood from the followingdescription thereof given by way of example only with reference to theaccompanying drawings, in which:

FIG. 1 is a perspective view of a surgical device according to theinvention;

FIG. 2 is a cross sectional view of the device of FIG. 1;

FIG. 3 is a cross sectional view of the device in one position of use;

FIG. 4 is a cross sectional view of the device in another position ofuse;

FIG. 5 is a top plan view of the device in the position of FIG. 4;

FIGS. 6 and 7 are respectively perspective and cross sectional viewsillustrating a method of forming the device of FIGS. 1 to 5;

FIG. 8 is a perspective view of another surgical device according to theinvention;

FIG. 9 is a cross sectional view of the device of FIG. 8 in one positionof use;

FIG. 10 is a cross sectional view of the device of FIG. 8 in anotherposition of use;

FIGS. 11 and 12 are cross sectional views of another surgical deviceaccording to the invention in different positions of use;

FIG. 13 is a plan view of the device of FIG. 11;

FIG. 14 is a cross sectional view of a further surgical device accordingto the invention;

FIGS. 15A and 15B are cross sectional views of the device of FIG. 14, inuse;

FIG. 16 is plan view of the device of FIG. 14;

FIG. 17 is a cross section view of another surgical device of invention;

FIG. 18 is a plan view of the device of FIG. 17;

FIG. 19 is a cross sectional view of another surgical device of theinvention;

FIG. 20 is a plan view of the device of FIG. 19;

FIG. 21 is a cross sectional view of a further surgical device of theinvention;

FIG. 22 is a cross sectional view of a still further surgical device ofthe invention;

FIG. 23 is plan view of the device of FIG. 22;

FIG. 24 is a perspective view of another surgical device of theinvention;

FIG. 25 is a perspective view of the device of FIG. 24 being adjusted;

FIG. 26 is a side, partially cross sectional view of the device of FIGS.24 and 25;

FIG. 27 is a view similar to FIG. 26 of the device partiallydisassembled;

FIG. 28 is a view similar to FIG. 26 with the device of FIG. 27re-assembled;

FIG. 29 is a diagrammatic perspective view of another surgical device ofthe invention;

FIG. 30 is a perspective view of the device of FIG. 29 in a woundinserting configuration;

FIGS. 31 and 32 are respectively diagrammatic perspective and plan viewsof an inner ring part of the device of FIGS. 29 and 30;

FIG. 33 is a cross sectional view of two surgical devices ready forassembly;

FIG. 34 is a cross sectional view of the devices of FIG. 33, assembled;

FIG. 35 is a plan view of another surgical device according to theinvention;

FIG. 36 is a cross sectional view on the line A—A in FIG. 35 with thedevice in position in an incision;

FIG. 37 is a plan view of the device of FIGS. 35 and 36 in anotherposition of use; and

FIG. 38 is a cross sectional view on the line B—B of FIG. 37.

DETAILED DESCRIPTION

Referring to the drawings and initially to FIGS. 1 to 7 thereof there isillustrated a surgical device, especially for use in laproscopicsurgery. The device 1 in this case is used in surgery involving anincision 2 in a wall 3 of a patients abdomen. The wound is, in thiscase, both protected and retracted by the device 1 of the invention.Thus, the invention in this case provides a wound protector retractor.

The device 1 comprises an inner mounting means in the form of an O-ring10 of flexible material such as of elastomeric material for insertionthrough the wound opening 2, an outer mounting means for mountingexternal of the wound opening 2 and a connecting means, in this case inthe form of a sleeve 11 extending between the inner 10 and outermounting means. The outer mounting means is movable, in this caserotatable, relative to the inner O-ring 10 to twist the sleeve 11 toform a centralised lumen 12 of reduced cross section and to shorten theaxial extent of the sleeve 11. As the sleeve 11 is twisted the innerO-ring 10 is drawn upwardly from the inserted position illustrated inFIG. 3 to the in-use position illustrated in FIG. 4 in which the woundis sealed and a radial retraction force is applied to the wound. Asurgeon inserts a sealed gloved hand/arm/instrument through the sealedand retracted wound to perform a surgical procedure within the abdomen.

In this preferred case the outer mounting means comprises a first outermounting means in the form of a first annular ring 20 and a second outermounting means in the form of a second annular ring 21. The sleeve 11 isof biocompatible pliable gas impermeable plastics material and isattached at one end to the ring 20 and at an opposite end to the ring21. The sleeve 11 is connected to the ring 20, led over the O-ring 10and back up for attachment to the ring 21 as best illustrated in FIG. 2.

In use, a surgeon makes an incision in the abdominal cavity and theO-ring 10 is flexed and inserted through the incision as illustrated inFIG. 3. The outer rings 20, 21 are then rotated relative to one anotherin the direction of the arrows A and B in FIG. 3. This relative rotationtwists the sleeve 11 and shortens the sleeve until the device is in theoperative position of FIG. 4. In this position the inner O-ring 10 isengaged against the inside of the interior of the anterior abdominalwall and the rings 21 and 22 are external of the wound opening with thesleeve 11 shortened in axial extent. The twisting of the sleeve 11provides a central lumen 12 of reduced size, which depends on the degreeof twist. A full 180° relative twist would result in closing down of thelumen. The reduced lumen 12 provides access for instruments and/or asurgeons arm while maintaining a wound seal.

Locking means of any suitable type may be provided to lock the rings 20,21 together. The locking means may, for example comprise a releasablelatching system such as a ratchet and pawl arrangement or the like.

Preferably a gas tight seal is formed between the rings 20, 21 in use.The sleeve in this case provides an inflatable space 30 between therings 20, 21 and the inner O-ring 10. An inflation connection port maybe provided in the device to facilitate inflation. On inflation, a woundengaging section 11 a of the sleeve is pushed radially outwardly toprovide a highly efficient wound protector/seal and wound retractor. Theinner sleeve section 11 b is inflated to further restrict the lumen 12and provide highly efficient sealing engagement with a surgeons forearm,a device or an instrument inserted through the lumen.

For efficient sealing engagement it is preferred that the inner diameter(d) of the sleeve 11 is greater than or equal to the axial length (l) ofthe sleeve 11 as illustrated in FIG. 7. Preferably the inner diameter ofthe sleeve is greater than the axial length of the sleeve by an amountwhich is less than the thickness of an average abdominal wall. With thisconfiguration on twisting of the sleeve 11, sealing and retractionforces are applied to the wound opening.

The surgical device 1 may be formed from a cylindrical sleeve 50 ofpliable plastic material attached to a pair of rings 20, 21 asillustrated in FIGS. 6 and 7. A flexible O-ring 10 is fitted over thesleeve 50. The flexible sleeve 50 is then turned over on itself so thatthe O-ring 10 is confined between inner and outer sleeve sections 11 a,11 b and the rings 20, 21 are in the configuration illustrated in FIGS.1 and 2.

The device of the invention applies a force to the wound edges toachieve adequate exposure without causing ischaemic injury to the woundedges. The device protects wound edges from cross infection or seedingby cancerous or otherwise malignant cells. Another advantage is that thedevice is sufficiently inexpensive that it can be disposed of after asingle use thereby obviating the need for cleaning and sterilisationbetween use. In addition, the device is simple to place into a desiredposition in a wound or natural bodily opening and easy to remove,especially without negating the benefits gained from use of the deviceas a wound protector.

Referring to FIGS. 8 to 10 there is illustrated another surgical device60 according to the invention. The device 60 is similar to the device 1and like parts are assigned the same reference numerals. In this casethe sleeve 61 is a single wall sleeve and there is only one outermounting ring 62. On rotation of the outer ring 62 relative to the innerring 10 a twist is formed in the sleeve which is shortened, drawing theinner ring 10 upwardly against the interior of the anterior abdominalwall as illustrated in FIGS. 9 and 10.

It will be appreciated that the inner O-ring may be fixed, for example,by adhesives to the sleeve of the surgical device. It will also beappreciated that one or more of the mounting means may be shaped topositively engage with tissue. For example, the mounting means mayinclude tissue-engaging projections to lock the mounting means inposition.

It will be appreciated that while for efficient retraction and woundprotection it is preferred that the connecting means between the outerand inner mounting means is in the form of a sleeve of pliable material,the connecting means may be discontinuous. For example the sleeve may bein the form of elongate strips or the like.

Referring to FIGS. 11 to 13 there is illustrated another surgical device70 according to the invention. In this case the connecting meanscomprises a plurality of straps 71 which are drawn upwardly to shortenthe axial extent and to form a wound retractor. The straps 71 areretained in the shortened configuration illustrated by any suitablelocking means such as by wedge elements 72. In this case an irisdiaphragm type device 80 is provided in the wound opening which isinflatable from the rest configuration illustrated in FIG. 11 to thepressurised inflated configuration illustrated in FIG. 12.

Referring to FIGS. 14 to 16 there is illustrated another device 85according to the invention in which the connecting means is defined by aplurality of straps 86 which are movable between an inner mounting ring83 and an outer mounting ring 84 by buckle devices 87 from the initialposition illustrated in FIG. 15B to the wound retracting position ofFIG. 15A. The inner ring 83 is first inserted though the incision. Theouter ring 82 is then brought down to skin level by taking up the slackin the straps 86. To achieve the retraction effect the straps 86 arepulled taut causing the wound edge to be displaced out from thecentrepoint of the wound. The straps 86 may be adjusted until optimumretraction is achieved. Tension in the straps 86 is maintained by thebuckles 86 which may hold the strap 86 taut either by friction or usinga clasp mechanism.

Referring to FIGS. 17 and 18 another surgical device 90 similar to thedevice 85 is illustrated. In this case the inner and outer mountingrings 82, 83 are of oval shape in transverse cross section to smooth themovement of the straps 86. This device operates in a similar manner tothe device 85.

Referring to FIGS. 19 and 20 there is illustrated another surgicaldevice 93 which has single legged straps 94. This device operates in asimilar manner to devices 85 and device 90. In this case straps 94 donot loop around the inner ring 83 but are directly attached to it.

Referring to FIG. 21 there is illustrated a further surgical device 95having straps 96 which are locked in position by a locking mechainism.The locking mechanism comprises a wedge 97 inserted into a hole throughwhich the strop 96 passes to hold the strap 96 in position by friction.A ratchet mechanism may also be used or some other adjustable lockingmechanism to hold the strap in position.

The device 98 illustrated in FIGS. 22 and 23 is similar to the device ofFIG. 21 except that a different construction of wedge or ratchet 99 isused to lock the straps in position.

Referring to FIGS. 24 to 26 there is illustrated another surgical deviceaccording to the invention. In this case the surgical device is a woundprotector retractor 200 of similar construction as that described abovewith reference to FIGS. 1 to 10. The device 1 comprises an innermounting means in the form of a first O-ring 201, a first outer mountingmeans in the form of a second O-ring 202 mounted in a first receiver203, and a second mounting means in the form of a third O-ring 205mounted in a second receiver 206. The receivers 203, 206 are in thiscase interconnectable as illustrated and a fourth O-ring 207 is providedbetween the receivers 203, 206 on assembly.

A sleeve 210 of flexible pliable plastics material extends from thesecond outer receiver 206 to the inner O-ring 201 and from the innerO-ring 201 to the first outer receiver 203. The receivers 203, 206 arede-mountable as illustrated in FIG. 25 to facilitate relative rotationtherebetween in the direction of the arrows to vary the degree of twistin the sleeve 210.

Referring to FIGS. 27 and 28 there is illustrated another surgicaldevice 220 which is similar to the device of FIGS. 24 to 26 and likeparts are assigned the same reference numerals. In this case the O-ring205 is de-mountable from the receiver 206 to facilitate lengthadjustment of the sleeve 210. On removal of the O-ring 205 the sleeve210 is adjusted to a desired length d. In this way a single device 220may be used for a variety of thickness of abdomens. The lumen diameterdefined by the twist does not need to be changed to cater for a range ofabdomen sizes. The excess sleeve may be cut off or wound around theO-ring seal 205.

Referring now to FIGS. 29 to 32 there is illustrated part 230 of anothersurgical device according to the invention which is similar to thedevices of FIGS. 24 to 28 and like parts are assigned the same referencenumerals. An inner mounting means 231 is configured to reduce the sizethereof for ease of insertion into a wound opening. In this case theinner mounting means 231 is in the form of a split ring which is hingedat 232 to facilitate a reduction in the diameter of the ring 231 asillustrated. It will of course be appreciated that the hinge may beintegrally formed and indeed, there may be a number of such hinges.

Referring to FIGS. 33 and 34 there is illustrated an assembly of twosurgical devices 250, 260. The device 250 is a forearm seal and thedevice 260 is a wound protector retractor which is assembled to an outersealing device 250. The sealing device 250 provides an outer sealedaccess port through which a surgeon may insert his forearm or forinsertion of an instrument or the like.

Referring to FIGS. 35 to 38 there is illustrated another surgical device300 according to the invention. The device 300 is a wound protectorretractor similar to those described above. In this case the woundprotector retractor 300 comprises an inner ring 301 of semi-rigidelastomeric material and an outer ring 302 which is of similar material.A sleeve 303 of pliable material extends between the rings 301, 302.Drawstrings 305 are fitted to the sleeve 303, the drawstrings beingpulled outwardly in the direction of the arrows to pull the sleeve 303upwardly to tighten in the incision and provide a wound protector andretractor.

The invention is not limited to the embodiments hereinbefore describedwhich may be varied in construction and detail.

1. A wound protector and retractor device, comprising: a longitudinalaxis; a distal ring; a proximal ring; and a sleeve extending at leastbetween the distal ring and the proximal ring, the sleeve being fixed tothe proximal ring at a first end portion of the sleeve, and a second endportion of the sleeve being slidingly received over a portion of theproximal ring.
 2. The wound protector and retractor device of claim 1,wherein the sliding of the second end portion of the sleeve over aportion of the proximal ring allows relative movement between the sleeveand the proximal ring to shorten an axial extent of the sleeve locatedbetween the distal ring and the proximal ring.
 3. The wound protectorand retractor device of claim 2, wherein the portion of the proximalring that slidingly receives the sleeve includes an outer portion of theproximal ring.
 4. The wound protector and retractor device of claim 1,wherein the second end portion of the sleeve is biased against theproximal ring.
 5. The wound protector and retractor device of claim 1,wherein the proximal ring is located within the sleeve.
 6. The woundprotector and retractor device of claim 1, wherein the proximal ringforms a part of a securing arrangement configured to substantially fixthe axial extent of the sleeve located between the distal ring and theproximal ring at a desired length.
 7. The wound protector and retractordevice of claim 6, wherein the securing arrangement further includes adrawstring coupled to the second end portion of the sleeve.
 8. The woundprotector and retractor device of claim 1, wherein the proximal ring isformed of an elastomeric material.
 9. The wound protector and retractordevice of claim 1, wherein the distal ring is formed of an elastomericmaterial.
 10. The wound protector and retractor device of claim 1,wherein the sleeve is wrapped around the distal ring.
 11. The woundprotector and retractor device of claim 1, wherein the sleeve has agenerally uniform cross-sectional size in a plane normal to thelongitudinal axis, the cross-sectional size of the sleeve beingsubstantially equal to a size of at least one of the proximal and distalrings.
 12. The wound protector and retractor device of claim 11, whereinthe cross-sectional size of the sleeve is substantially equal to a sizeof both of the proximal and distal rings.
 13. The wound protector andretractor device of claim 1, wherein an inner diameter of the proximalring is substantially equal to an inner diameter of the distal ring. 14.The wound protector and retractor device of claim 1, wherein theproximal ring and distal ring are substantially equal in size.
 15. Thewound protector and retractor device of claim 1, wherein at least one ofthe proximal and distal rings includes a substantially circular shape.16. The wound protector and retractor device of claim 15, wherein bothof the proximal and distal rings include a substantially circular shape.17. The wound protector and retractor device of claim 1, wherein atleast one of the proximal and distal rings includes a circularcross-section in a plane containing the longitudinal axis.
 18. The woundprotector and retractor device of claim 17, wherein both of the proximaland distal rings include a circular cross-section in planes containingthe longitudinal axis.
 19. A method for retracting an incisioncomprising the steps of: making an incision in a patient; providing awound retractor comprising a central longitudinal axis, a distal ring, aproximal ring, and a sleeve extending at least between the distal ringand the proximal ring, the sleeve being fixed to the proximal ring at afirst end portion of the sleeve, and a second end portion of the sleevebeing slidingly received over a portion of the proximal ring; insertingthe distal ring through the incision such that the sleeve extendsthrough the incision and the proximal ring is located outside of theincision; and moving the sleeve relative to the proximal ring to shortenan axial extent of the sleeve located between the distal ring and theproximal ring.
 20. A method as claimed in claim 19, wherein the step ofmoving the sleeve relative to the proximal ring includes sliding aportion of the sleeve against a radially outer portion of the proximalring.
 21. A method as claimed in claim 19, wherein the proximal ring islocated radially within an end portion of the sleeve.
 22. A method asclaimed in claim 19, further comprising the step of securing the sleeveto maintain the shortened axial extent of the sleeve located between thedistal ring and the proximal ring.
 23. A method as claimed in claim 22,wherein the step of moving the sleeve relative to the proximal ringincludes tightening a drawstring coupled to a proximal end portion ofthe sleeve.
 24. A method as claimed in claim 23, wherein the step ofsecuring the sleeve includes fixing the drawstring in the tightenedposition.
 25. A method as claimed in claim 19, wherein a portion of thesleeve located between the distal ring and the proximal ring includestwo material layers.
 26. A method as claimed in claim 25, wherein thesleeve is wrapped around the distal ring to form the two materiallayers.
 27. A method as claimed in claim 26, wherein the distal ring isformed of an elastomeric material.
 28. A method as claimed in claim 27,wherein the proximal ring is formed of an elastomeric material.
 29. Amethod as claimed in claim 19, wherein the sleeve has a generallyuniform cross-sectional size in a plane normal to the longitudinal axis,the cross-sectional size of the sleeve being substantially equal to asize of at least one of the proximal and distal rings.
 30. A method asclaimed in claim 29, wherein the cross-sectional size of the sleeve issubstantially equal to a size of both of the proximal and distal rings.31. A method as claimed in claim 19, wherein an inner diameter of theproximal ring is substantially equal to an inner diameter of the distalring.
 32. A method as claimed in claim 19, wherein the proximal ring anddistal ring are substantially equal in size.
 33. A method as claimed inclaim 19, wherein at least one of the proximal and distal rings includesa substantially circular shape.
 34. A method as claimed in claim 33,wherein both of the proximal and distal rings include a substantiallycircular shape.
 35. A method as claimed in claim 19, wherein at leastone of the proximal and distal rings includes a circular cross-sectionin a plane containing the longitudinal axis.
 36. A method as claimed inclaim 35, wherein both of the proximal and distal rings include acircular cross-section in planes containing the longitudinal axis.